Job Summary:
The Senior, Quality Systems Engineer shall drive TMC’s efforts to ensure compliance with applicable global Quality System regulations (i.e., 21 CFR Part 820, ISO 13485:2016, EUMDR etc.) in an efficient manner.
Job Details:
- Support the management and effectiveness of the Quality Management System, primarily the CAPA system by:
- Providing guidance to CAPA Teams
- Participating on CAPA Teams as needed
- Reviewing content of CAPA root cause investigations, corrective actions, effectiveness criteria, and supporting data for adequacy, logicality, completeness, and compliance to regulatory and procedural requirements
- Being responsible for approving corrective and preventive action plans, implementation of required activities and objective evidence, and effectiveness verification
- Teaching and mentoring CAPA owners on root cause analysis and technical writing
- Organizing the Stewardship reviews of CAPA documentation
- Managing the CAPA portfolio of projects to ensure these issues are being managed in a timely and compliant manner
- Establishing and maintaining CAPA process metrics
- Leading activities related to the CAPA Board Work with Organizational Stakeholders to ensure CAPA and other quality system requirements are well understood appropriately incorporated into CAPA documentation and Management Review
- Generate Quality System Standard Operating Procedures
- Develop of Quality System training materials, and deliver training where applicable
- Contribute to the development of Quality System performance measures
- Lead third-party audit activities as required
- Other duties as assigned
Position Requirements:
Knowledge, Skills and Abilities (KSAs)
- Demonstrated knowledge in 21 CRF Part 820, ISO 13485:2016, Medical Device Directive / Regulation
- Strong computer knowledge (MS Office), technical writing skills and proofreading ability
- Strong ability to develop, communicate, and support the interpretation and implementation of comprehensive quality systems/regulatory requirements.
- Advanced skill in developing and maintaining spreadsheets, pivot tables, metrics, statistical applications, charts/graphs, and user-friendly reports
- Demonstrated ability to lead a group of participants from problem statement, root cause identification, and verification of effectiveness
- Demonstrated ability to interact with all levels of managements, co-workers, and regulators
- Must possess strong decision-making and prioritization skills
- Must possess strong written, verbal, and interpersonal communication skills
Background Experiences
- Position requires a 4-year degree in engineering or a scientific discipline or equivalent combination of education and work experience
- Minimum 8 years’ experience in a Quality Engineering, Compliance, or other related Quality System role(s) in a medical device or pharmaceutical company
- Experience performing root cause analysis/investigations
- Experience supporting a regulated manufacturing operation
- Experience with electronic quality system tools
- Six Sigma Black/Green Belt Certification preferred
- ISO 13485 Lead Auditor Certification preferred
Employee Value Proposition:
We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.?
At Terumo we believe in the power of personal growth and will encourage you to get in the driver’s seat – progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what’s next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, sustainable solutions for patients.
Join us, and help shape wherever we go next!
Advancing healthcare with heart